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NCT Number: NCT06375473

Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients

This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with pancreatic ductal adenocarcinoma diagnosed by pathology or imaging;
  • Age ≥18 years old, male or female;
  • Patients receiving treatment based on irinotecan hydrochloride liposome injection II;
  • The subjects voluntarily joined the study and signed the informed consent.

Exclusion criteria

  • Confirmed pregnant or lactating women;
  • The researchers determined that other conditions were not suitable for inclusion in the study.

Treatment and study plan

Irinotecan liposome II combination therapy regimen

Drug

Irinotecan liposome II combination therapy regimen

Primary outcomes

  1. rwTEAE

    Time frame: 3 years

    real word treatment emergent adverse event

Secondary outcomes

  1. OS

    Time frame: 3 years

    real word overall survival

  2. PFS

    Time frame: 3 years

    real word progression free survival

  3. ORR

    Time frame: 3 years

    real word objective response rate

  4. TTP

    Time frame: 3 years

    real word time to progression

  5. DCR

    Time frame: 3 years

    real word disease control rate

Study contacts

Contact information is provided by the study sponsor or research team.

Taiping Zhang, doctor

CONTACT

[email protected]

+86 13520132976

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Acronym: MA-PC-RWS-011

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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